MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO MODIFICATION OF JELCO, JELCO-W AND JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	305006
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device is unknown; no additional information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Initial visual examination of the catheter assembly displayed kinking in the catheter tube with no evidence of catheter securement issues or bevel tip irregularities.Magnified examination of the catheter assembly displayed evidence of a "v"shaped tear in the catheter tubing above the catheter hub nose.This "v" shape incision is consistent with a catheter wall penetration by the cannula as a result of a redirect during deployment and not the result of a manufacturing nonconformance.The root cause of the reported issue was found to be due to a variation in insertion technique.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the needle came out the side during insertion.No patient injury was reported.

• Brand Name: JELCO MODIFICATION OF JELCO, JELCO-W AND JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15397868
• Report Number: 3012307300-2022-18553
• Device Sequence Number: 17667944
• Product Code: FOZ
• UDI-Device Identifier: 10351688071118
• UDI-Public: 10351688071118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/01/2023
• Device Model Number: 305006
• Device Catalogue Number: 305006
• Device Lot Number: 3981843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown